Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 10:40 PM
Ignite Modification Date: 2025-12-25 @ 8:11 PM
NCT ID: NCT00815035
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Study: NCT00815035
Study Brief: Oral Immunotherapy (OIT) for Peanut Allergy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Blinded Phase-Peanut OIT Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT. Peanut OIT: Peanut flour that is orally ingested in a graded fashion. 0 None 0 10 10 10 View
Blinded Phase-Placebo Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour. Placebo: Oat flour used as a placebo that is orally ingested a graded fashion 0 None 0 6 4 6 View
Open Label Phase-Peanut OIT Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion. 0 None 0 15 15 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oropharyngeal itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Coughing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lip or eye swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Erythematous rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Itchy nose SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin itch SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eye itch SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye tearing SYSTEMATIC_ASSESSMENT Eye disorders None View
Hives SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View